A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 29, 2025

Primary Completion Date

January 31, 2027

Study Completion Date

June 30, 2027

Conditions
Colon CancerRectal CancerColorectal CancerColorectal Cancer (CRC)
Interventions
DRUG

fruquintinib

Participants will receive oral fruquintinib, with or without food, for the first 21 days of each 28-day cycle.

DRUG

FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)

Participants will receive FOLFIRI once every 2 weeks on day 1 of every 28-day cycle (twice in each cycle). The FOLFIRI regimen consists of irinotecan given 180 mg/m2 intravenous infusion (IV), leucovorin 400 mg/m2 (or 200 mg/m2 levoleucovorin) IV, followed by 5-fluorouracil (5-FU) 400 mg/m2 bolus injection and 5-FU continuous IV infusion of 2400 mg/m2 over 46 to 48 hours.

Trial Locations (10)

21044

RECRUITING

Maryland Oncology Hematology, Columbia

24153

RECRUITING

Blue Ridge Cancer Care (Oncology & Hematology Associates of Southwest VA), Salem

37203

RECRUITING

SCRI Oncology Partners, Nashville

55369

RECRUITING

Minnesota Oncology Hematology - Primary, Maple Grove

75702

RECRUITING

Texas Oncology - Northeast Texas, Tyler

77702

RECRUITING

Texas Oncology - Gulf Coast, Beaumont

78705

RECRUITING

Texas Oncology - Central/South Texas, Austin

80218

RECRUITING

Rocky Mountain Cancer Center - Primary, Denver

97213

RECRUITING

Northwest Cancer Specialists - Compass, Portland

97401

RECRUITING

Oncology Associates of Oregon - Primary, Eugene

All Listed Sponsors
collaborator

Takeda Development Center Americas, Inc.

INDUSTRY

lead

SCRI Development Innovations, LLC

OTHER

NCT07011576 - A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC) | Biotech Hunter | Biotech Hunter